Table 1.
Finland | England | Canada | USA | |
---|---|---|---|---|
Type of research handled | Medical | Within NHS; specific typesa | Human and health care | Human and health care |
Specific research law | Yes, medical research | No | No | Yes, general |
Main basis | Law | Health Ministry rules | Requirements from national grant agency | Government rules |
Special law for drug trials | EU clinical trials directive, national laws | EU clinical trials directive, national laws | Drug and devices law | Drug, devices and food law |
Leading document | No single | No single | Tri-Council statementb | Common rule |
Helsinki declaration | Separate document | Separate document | Some parts integrated in leading document | Some parts integrated in leading document |
International Committee on Harmonization (drug trials) Good Clinical Practice guidelines | Separate document for drug trials | Integrated to rules | Integrated in leading document | Integrated in leading document |
aRegardless of place, a certain type of research, such as investigational drugs and devices, adults lacking capacity to consent, exposure to ionizing radiation.
bTri-Council statements, tri-council policy statement: ethical conduct for research involving humans.